Olympus Pk-Tp System Reactive Control
FDA 510(k) K894617 · Schiff & Co.
510(k) numberK894617
Submission
- Device name
- Olympus Pk-Tp System Reactive Control
- Applicant
- Schiff & Co.
West Cadwell, NJ, US - Received
- July 20, 1989
- Decision date
- October 31, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GMI – Antigen, Cf And / Or Id, Coccidioides Immitis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3135
- Specialty
- Microbiology
Other 510(k)s with product code GMI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K812190 | Coccidioides Immunodiffusion SystemGMI · Traditional | American Scientific Products | 08/31/1981SE |
| K812185 | Fungal Immunodiffusion SystemGMI · Traditional | American Scientific Products | 08/25/1981SE |
| K802129 | Immunodiffusion Reagents/SerologicalGMI · Traditional | Nolan Biological Laboratories, Inc. | 09/26/1980SE |
| K792716 | Candida Albicans, AntigenGMI · Traditional | Meridian Diagnostics, Inc. | 01/24/1980SE |
| K792713 | Candida Albicans, AntiserumGMI · Traditional | Meridian Diagnostics, Inc. | 01/23/1980SE |
| K792689 | Coccidioides Immitis, AntigenGMI · Traditional | Meridian Diagnostics, Inc. | 01/17/1980SE |
| K792682 | Coccidioides Immitis, AntigenGMI · Traditional | Meridian Diagnostics, Inc. | 01/17/1980SE |
| K791389 | Coccidioides Antigen #CF10023XGMI · Traditional | Immuno-Mycologics, Inc. | 08/16/1979SE |
| K791383 | Candida Immunodiffusion Kit #CA1001GMI · Traditional | Immuno-Mycologics, Inc. | 08/16/1979SE |
| K770527 | Candida Immunodiffusion KitGMI · Traditional | I M, Inc. | 03/17/1978SE |
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|---|---|---|
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| K981629 | Nutrisafe Enteral Feeding TubeFPD · Traditional | 02/04/1999SE |
| K981630 | Vygon Double Lumen Umbilical CatheterFOS · Traditional | 10/01/1998SE |
| K974141 | Plus Reusable ResuscitatorBTM · Traditional | 05/21/1998SE |
| K954448 | Viotec V-2200 Ultraviolet Germicidal Air Purification SystemFRA · Traditional | 10/28/1996SE |
| K955085 | Hm-Cap Eia Test (Modification)LYR · Traditional | 02/09/1996SE |
| K944159 | Hm-Cap Eia KitLYR · Traditional | 07/18/1995SE |
| K943521 | Viotec 1400 Series Ultraviolet Germicidal FixtureFRA · Traditional | 02/14/1995SE |
| K896684 | Kemble Liquid Handling System DispenserJQW · Traditional | 04/16/1990SE |
Questions and answers
When was Olympus Pk-Tp System Reactive Control cleared by the FDA?
Olympus Pk-Tp System Reactive Control (K894617) received a 510(k) decision of Substantially Equivalent on October 31, 1989, 103 days after the submission was received.
What is the product code of K894617?
The FDA product code is GMI – Antigen, Cf And / Or Id, Coccidioides Immitis, a Class II (moderate risk) device regulated under 21 CFR 866.3135.